Request for Modification to External IRB Studies for Local UTHSCSA Approval

Request for Modification to External IRB Studies for Local UTHSCSA Approval

Request for Modification to External IRB Studies for Local UTHSCSA Approval

Protocol Tracking Number:

Principal Investigator:

Steps to submitting a modification request:

  1. Use the most current OCR approved forms (which were emailed to you from the OCR with the Activation Letter)
  2. Make necessary changes to existing OCR approved forms using tracked changes, and/or
  3. Develop new forms for submission, and
  4. Complete this modification request and
  5. Submit all forms with tracked changes and include approval letter from External IRB (where applicable) to , copying the PI

This modification request is for the following: (check all that apply):

Type of change: / Consider form changes and/or IRB Approval: / Reason for the change or addition:
1. / Institutional Component
Changes to the institutional research application (e.g. point of contact, list of identifiers used, sharing or storage of data/specimens, drug/device storage) / Institutional Research Application (previously Step 1, Step 2-Inst), IRB approval letter
2. / Coverage Analysis / Coverage Analysis Form, IRB approval letter
3. / Informed Consent (Only for revised injury statements or surrogate consent form changes)
NOTE: OCR does not need to review all revised informed consent changes if the IRB of record provides a site specific final “IRB Approved” informed consent document that already contains UTHSCSA specific local contact information. However, OCR may request to see all informed consent document changes if the IRB of record only provides an example consent form. (e.g. NCI IRB). / Forms D, D-2, H-1, IRB approval letter
4. / HIPAA Authorization / Forms D, D-2, H-1, IRB approval letter
5. / Local study staff engaged in research / Forms B-2, Step 2-Inst or Inst M
6. / Conflict of Interest disclosure / Form X
7. / Local principal investigator
Change of PI must be approved by the IRB of Record. This letter must be included with the modification. / Forms A, B-2, D, D-2, Institutional Research Application (previously Step 1, Step 2-Inst) Inst M, IRB approval letter
Yes No, Will the PI be leaving the institution and transferring research data to a new institution?
If Yes, What type of data will the PI be transferring?
Identifiable Data
De-Identifiable Data
8. / Change to research that affects local safety committee approvals
Radiation Safety Committee
Radioactive Drug Research Committee
Institutional Biosafety Committee
Other; Specify: / Institutional Research Application (previously Step 2-Inst), Forms Q, Q-1, D, D-2, IRB approval letter
9. / Patient Payment / Forms Inst B , D, D-2, IRB approval letter
10. / Sites / Institutional Research Application (previously Step 1, Step 2-Inst, Form B) Forms D, D-2, IRB approval Letter
11. / Other, Specify:

V 10/25/2018

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